1. Field of the Invention
The subject invention relates to monoclonal antibodies reactive with antigenic determinants present on the stratum corneum of human epidermis and uses thereof.
In particular, the invention relates to a monoclonal antibody, referred to as BC 21, which is useful as reagent in the treatment and diagnosis of dermatological diseases and diseases of the internal epithelia.
2. Background Information
It is known that the epidermis contains a basal membrane on which rest a layer of proliferative basal cells and layers of suprabasal cells, comprising the stratum spinosum and the stratum granulosum. These are layers of cells undergoing differentiation which become gradually keratinized and ultimately form, on the skin surface, a corneous layer (stratum corneum) composed of dead, completely keratinized cells, i.e., corneocytes. Corneocytes are formed mainly from keratin filaments which are enclosed by a very strong membrane called the corneous sheath. This corneous sheath is formed by precursor proteins linked by covalent bonds when acted upon by a specific enzyme called transglutaminase.
To study skin diseases, for example, psoriasis, acne, warts, papillomas and cancers, differentiation of the normal cells of the epidermis called keratinocytes must be better understood. As defined in the present invention, the term "normal" signifies "non-pathological." In order to undertake these studies, various markers of the terminal differentiation of the keratinocytes must be made available. A need exists in the field to identify terminal differentiation markers of the epidermis with antibodies specific for these determinants.
The present invention discloses the preparation and characterization of antibodies capable of recognizing antigenic determinants found on stratum corneum of normal human epidermis origin. Antibodies of this type are capable of reacting specifically with the stratum corneum on a non-pathological section of human epidermis. These new antibodies are potentially useful for the treatment and diagnosis of many forms of keratinization disorders such as ichthyosis, psoriasis and eczema.